and that are listed in this subpart as safe in color additive mixtures for coloring foods.

(b) Specifications. Annatto extract, Including pigments precipitated thereFrom, shall conform to the following specifications:

(1) Arsenic (as As), not more than 3 parts per million; lead as Pb, not more than 10 parts per million.

(2) When solvents listed under paragraph (a) (1) (ii) of this section are used, annatto extract shall contain no more solvent residue than is permitted of the corresponding solvents in spice oleoresins under applicable food additive regulations in Part 121 of this chapter.

(c) Uses and restrictions. Annatto extract may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.

(d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of § 8.32. Labels shall bear information showing that the color is derived from annatto seed. The requirements of § 8.32(a) that all ingredients shall be listed by name shall not be construed as requiring the declaration of residues of solvents listed in paragraph (a) (1) (ii) of this section.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [33 F.R. 8814, June 18, 1968]

§ 8.306 Tagetes (Aztec marigold) meal and extract.

(a) Identity. (1) The color additive tagetes (Aztec marigold) meal is the dried, ground flower petals of the Aztec marigold (Tagetes erecta L.) mixed with not more than 0.3 percent ethoxyquin.

(2) The color additive tagetes (Aztec marigold) extract is a hexane extract of the flower petals of the Aztec marigold (Tagetes erecta L.). It is mixed with an edible vegetable oil, or with an edible vegetable oil and a hydrogenated edible vegetable oil, and not more than 0.3 percent ethoxyquin. It may also be mixed with soy flour or corn meal as a carrier.

All determinations, except the hexane residue, shall be made on the initial extract of the flower petals (after drying in a vacuum oven at 60° C. for 24 hours) prior to the addition of the oils and ethoxyquin. The hexane determination shall be made on the color additive after the addition of the vegetable oils, hydrogenated vegetable oils, and ethoxyquin.

(c) Uses and restrictions. The color additives tagetes (Aztec marigold) meal and extract may be safely used in chicken feed in accordance with the following prescribed conditions:

(1) The color additives are used to enhance the yellow color of chicken skin and eggs.

(2) The quantity of the color additives incorporated in the feed is such that the finished feed:

(1) Is supplemented sufficiently with xanthophyll and associated carotenoids so as to accomplish the intended effect described in subparagraph (1) of this paragraph; and

(ii) Meets the tolerance limitation for ethoxyquin in animal feed prescribed in § 121.202 of this chapter.

(d) Labeling requirements. The label of the color additives and any premixes prepared therefrom shall bear, in addition to the information required by § 8.32:

(1) A statement of the concentrations of xanthophyll and ethoxyquin contained therein.

(2) Adequate directions to provide a final product complying with the limitations prescribed in paragraph (c) of this section.

(e) Exemption from certification. Certification of this color additive is not

necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [31 F.R. 5070, Mar. 29, 1966]

§ 8.307 Paprika.

(a) Identity. (1) The color additive paprika is the ground dried pod of mild capsicum (Capsicum annuum L.). The definition of paprika in this paragraph is for the purpose of identity as a color additive only and shall not be construed as setting forth an official standard for paprika under section 401 of the act.

(2) Color additive mixtures made with paprika may contain as diluents only those substances listed in this Subpart D as safe and suitable in color additive mixtures for coloring foods.

(b) Uses and restrictions. Paprika may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 8.32.

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706 (c) of the act. [31 F.R. 1064, Jan. 24, 1966]

§ 8.308 Paprika oleoresin.

(a) Identity. (1) The color additive paprika oleoresin is the combination of flavor and color principles obtained from paprika (Capsicum annuum L.) by extraction, using any one or a combination of the following solvents:

(2) Color additive mixtures made with paprika oleoresin may contain as diluents only those substances listed in this Subpart D as safe and suitable in color additive mixtures for coloring foods.

(b) Specifications. Paprika oleoresin shall contain no more residue of the solvents listed in paragraph (a)(1) of this section than is permitted of the corresponding solvents in spice oleoresins under applicable food additive regulations in Part 121 of this chapter.

(c) Uses and restrictions. Paprika oleoresin may be safely used for the coloring of foods generally in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(d) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 8.32.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [31 F.R. 1064, Jan. 27, 1966]

any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 8.32.

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [31 F.R. 1064, Jan. 27, 1966]

§ 8.310 Turmeric oleoresin.

(a) Identity. (1) The color additive turmeric oleoresin is the combination of flavor and color principles obtained from tumeric (Curcuma longa L.) by extraction using any one or a combination of the following solvents:

The definition of turmeric oleoresin in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for turmeric oleoresin under section 401 of the act.

(2) Color additive mixtures made with turmeric oleoresin may contain as diluents only those substances listed in this Subpart D as safe and suitable in color additive mixtures for coloring foods.

(b) Specifications. Turmeric oleoresin shall contain no more residue of the solvents listed under paragraph (a) (1) of this section than is permitted for the corresponding solvents in spice oleoresins under applicable food additive regulation in Part 121 of this chapter.

(c) Uses and restrictions. Turmeric oleoresin may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(d) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 8.32.

(e) Exemption from certification. Certification of this color additive is not

(a) Identity. (1) The color additive saffron is the dried stigma of Crocus sativus L. The definition of saffron in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as setting forth an official standard for saffron under section 401 of the act.

(2) Color additive mixtures made with saffron may contain as diluents only those substances listed in this Subpart D as safe and suitable in color additive mixtures for coloring foods.

(b) Uses and restrictions. Saffron may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 8.32.

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [31 F.R. 1064, Jan. 27, 1966]

§ 8.313 Fruit juice.

(a) Identity. (1) The color additive fruit juice is the concentrated or unconcentrated liquid expressed from mature varieties of fresh, edible fruits, or is a water infusion of the dried fruit. The definition of fruit juice in this paragraph is for the purpose of identity as a color additive only and shall not be construed as a standard of identity under section 401 of the act. However, where a standard of identity for a particular fruit juice has been promulgated under section 401 of the act, it shall conform to such standard.

(2) Color additive mixtures made with fruit juice may contain as diluents only those substances listed in this Subpart

D as safe and suitable in color additive mixtures for coloring foods.

(b) Uses and restrictions. Fruit juice may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 8.32.

(d) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health, and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [31 F.R. 1065, Jan. 27, 1966]

§ 8.314 Vegetable juice.

(a) Identity. (1) The color additive vegetable juice is the concentrated or unconcentrated liquid expressed from mature varieties of fresh, edible vegetables. The definition of vegetable juice in this paragraph is for the purpose of identity as a color additive only, and shall not be construed as a standard of identity under section 401 of the act. However, where a standard of identity for a particular vegetable juice has been promulgated under section 401 of the act, it shall conform to such standard.

(2) Color additive mixtures made with vegetable juice may contain as diluents only those substances listed in this Subpart D as safe and suitable in color additive mixtures for coloring foods.

(b) Uses and restrictions. Vegetable juice may be safely used for the coloring of foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards or identity have been promulgated under section 401 of the act, unless the use of added color is authorized by such standards.

(c) Labeling. The color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall bear, in addition to the other information required by the act, labeling in accordance with the provisions of § 8.32.

(a) Identity. (1) The color additive toasted partially defatted cooked cottonseed flour is a product prepared as follows: Food quality cottonseed is delinted and decorticated; the meats are screened, aspirated, and rolled; moisture is adjusted, the meats heated, and the oil expressed; the cooked meats are cooled, ground, and reheated to obtain a product varying in shade from light to dark brown.

(2) Color additive mixtures for food use made with toasted partially defatted cooked cottonseed flour may contain only diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods.

(b) Specifications. Toasted partially defatted cooked cottonseed flour shall conform to the following specifications: Arsenic: It contains no added arsenic compound and therefore may not exceed a maximum natural background level of 0.2 part per million total arsenic, calculated as As.

Lead (as Pb), not more than 10 parts per million.

Free gossypol content, not more than 450 parts per million.

(c) Uses and restrictions. The color additive toasted partially defatted cooked cottonseed flour may be safely used for coloring foods generally, in amounts consistent with good manufacturing practice, except that it may not be used to color foods for which standards of identity have been promulgated under section 401 of the act, unless added color is authorized by such standards.

(d) Labeling. The label of the color additive and any mixtures prepared therefrom and intended solely or in part for coloring purposes shall conform to the requirements of § 8.32.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are exempt from the certification requirements of section 706(c) of the act. [33 F.R. 8814, June 18, 1968]

§ 8.316 Titanium dioxide.

(a) Identity. (1) The color additive titanium dioxide is synthetically prepared TiO2, free from admixture with other substances.

(2) Color additive mixtures for food use made with titanium dioxide may contain only those diluents that are suitable and that are listed in this subpart as safe in color additive mixtures for coloring foods, and the following: Silicon dioxide, SiO, and/or aluminum oxide, Al,O2, as dispersing aids-not more than 2 percent total.

(b) Specifications. Titanium dioxide shall conform to the following specifications:

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 1 part per million.

Antimony (as Sb), not more than 2 parts per million.

Mercury (as Hg), not more than 1 part per million.

Loss on ignition at 800° C. (after drying for 3 hours at 105° C.), not more than 0.5 percent.

Water soluble substances, not more than 0.3 percent.

Acid soluble substances, not more than 0.5 percent.

TIO,, not less than 99.0 percent after drying for 3 hours at 105° C.

Lead, arsenic, and antimony shall be determined in the solution obtained by boiling 10 grams of the titanium dioxide for 15 minutes in 50 milliliters of 0.5N hydrochloric acid.

(c) Uses and restrictions. The color additive titanium dioxide may be safely used for coloring foods generally, subject to the following restrictions:

(1) The quantity of titanium dioxide does not exceed 1 percent by weight of the food.

(2) It may not be used to color foods for which standards of identity have been promulgated under section 401 of the act unless added color is authorized by such standards.

(d) Labeling. The label of the color additive and any mixtures intended solely or in part for coloring purposes prepared therefrom shall conform to the requirements of § 8.32.

(e) Exemption from certification. Certification of this color additive is not necessary for the protection of the public health and therefore batches thereof are

(3) Color additive mixtures for food use made with cochineal extract or carmine may contain only diluents that are suitable and that are listed in this Subpart D as safe in color additive mixtures for coloring foods.

(b) Specifications. (1) Cochineal extract shall conform to the following specifications:

pH, not less than 5.0 and not more than 5.5 at 25° C.

Protein (N x 6.25), not more than 2.2 percent.

Total solids, not less than 5.7 and not more than 6.3 percent.

Methyl alcohol, not more than 150 parts per million.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 1 part per million.

Carminic acid, not less than 1.8 percent.

(2) Carmine shall conform to the following specifications:

Volatile matter (at 135° C. for 3 hours), not more than 20.0 percent.

Ash, not more than 12.0 percent.

Lead (as Pb), not more than 10 parts per million.

Arsenic (as As), not more than 1 part per million.

Carminic acid, not less than 50.0 percent. Carmine and cochineal extract shall be pasteurized or otherwise treated to destroy all viable Salmonella micro-organisms. Pasteurization or such other treatment is deemed to permit the adding of safe and suitable substances (other than chemical preservatives) that are essential to the method of pasteurization or other treatment used. For the purposes of this paragraph, safe and suitable sub